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Clinical Trials Office

博彩网址大全临床试验办公室支持创新临床试验 investigative research at the 博彩网址大全 School of Medicine.

School of Medcine building and fountain
 

我们的办公室为行业赞助的试验提供临床试验管理,包括 对试验的监督和对其行政、商业、教育、 regulatory and operational functions.

临床试验办公室简化了研究合同的处理 与行业合作伙伴一起制定预算,以促进临床试验的绩效 at the Saint Louis University School of Medicine.

该办公室还集中了重要的行政职能,并建立了标准 policies and procedures for successful management of clinical trials. This ensures the ease of use and proper documentation of all trial procedures.  

A Letter from the Clinical Trials Office

Dear 博彩网址大全 Research Community, 

我们很高兴地与大家分享,我们的临床试验办公室在过去的十年中发展迅速 past year. With that growth comes new services that the CTO. can offer you and your study teams. 我们想向大家介绍三位新的临床首席研究协调员 首席技术官已经聘请他作为博彩网址大全医学院所有部门的资源. Marisol Tahan, Amy Weisguth和Jennifer Lednicky都有各种各样的经验 在临床研究中,均可协助临床研究的各个方面 activities in the SOM.

首席技术官内部的临床主要研究协调员被聘为浮动人员 coordinators for all CRUs in need of coordinator services; services include:

  • Recruitment
  • Enrolling
  • Consenting
  • Scheduling
  • Data collection or processing
  • Regulatory assistance

可以提供临时或长期的服务,以填补工作人员的空缺. 这些工作人员也可以为新的或当前的研究提供教学机会 coordinators.

如果您有兴趣在您的研究时间内得到他们的帮助,请填写 the CTO Research Services Intake Form. 我们想向您介绍我们新的临床首席研究协调员 some background information about them. 

Marisol Tahan(发音为MEH-ree-soul TAY-han)担任临床负责人 临床试验办公室研究协调员,于2023年加入 a collaborative research services team. With a solid background spanning seven years 在临床研究和临床研究管理硕士学位,玛丽索尔作出了贡献 有意义的是赞助的试验,联邦资助的研究,和各个方面 包括阿尔茨海默病研究、临床软件开发、 Q.A. & Q.C., global clinical operations, and more. Notably, she emphasizes the importance 成功招募、保留和坚持的参与者关系. 玛莉索以务实著称,她利用科技来加强临床 research practices. Her dedication to positive change and compassionate leadership makes her an asset to the research community.

Amy Weisguth是临床试验办公室的临床首席研究协调员. 她在华盛顿有八年的临床研究协调员经验 University as well as PPD/Thermo Fisher. She has worked on a variety of clinical trials both federally funded by the NIH and industry-sponsored. Amy has worked in obstetrics and gynecology, gynecologic oncology, general medicine, and vaccine trials. She is 精通面向患者的研究活动,从患者同意到 recruitment to specimen collection and processing. Amy prides herself on her ability 发展与病人的关系,并对她的项目产生积极影响. 她热衷于帮助他人,并为临床研究的进步做出贡献. 作为临床试验办公室的一员,艾米将能够为这些需求做出贡献 of various departments with a focus on recruitment planning and execution.

Jennifer Lednicky加入博彩网址大全担任临床首席研究协调员 临床试验办公室,非常高兴能协助扩大研究 across 博彩网址大全. Jennifer has six plus years of experience as a clinical research coordinator 她在华盛顿大学儿童精神病学系工作,并获得了硕士学位 applied health Behavior Research from Wash U Medical School. In her time at Wash U, 詹妮弗参与了多项关于大脑发育的临床研究 以及儿童/婴儿治疗,以解决儿童焦虑和其他心理健康问题 disorders. Jennifer在收集临床研究的各个方面都有经验 试验数据,申请资金,获得IRB批准,研究启动等等 way to study closeout, dissemination and publication. Within the various studies Jennifer ,她建立了标准的sop,并执行了各种程序,包括 informed consent, Redcap, ct.gov submissions, data collection (including fMRI scans, eye tracking, behavioral assessments, and psychiatric diagnostic interviews). Jennifer 热衷于为改善医疗保健的项目做出贡献 and treatments for the public. She is motivated to learn and assist with any research needs across all departments here at 博彩网址大全

谢谢你的时间,如果你对Marisol, Amy和Jennifer感兴趣的话 help with your research time, please fill out the CTO Research Services Intake Form.  

Best,
Clinical Trials Office

Clinical Trial Employee Portal

*博彩网址大全 email needed to access portal.*

Purpose Statement

博彩网址大全医学院的主要目的是临床试验 办公室的目的是提高效率并鼓励各国之间的研究工作协调 clinical departments.

To achieve this, the office:

  • 通过标准化的政策和方法,促进合同和预算的处理 procedures.
  • Provides training and education to clinical research personnel.
  • 作为包括协调员在内的所有研究人员的信息资源; investigators and business managers.
  • 与SSM博彩网址大全医院就审批流程进行协调 特别关注医疗保险分析和其他必要的监管活动.

为了实现其目标,博彩网址大全临床试验办公室与适当的部门合作 input, will:

  • Act as the office of record for all contract documents.
  • Track the projects and contracts.
  • Negotiate the terms of the contract in consultation with departments.
  • Assist with budget preparation and negotiation, if needed, before approval.
  • Assist with compliance regarding research issues.
  • Collect data for internal and external audit purposes.
  • Coordinate amendments and contract terminations.
  • Assist departments in the preparation of paperwork for studies.
  • Maintain an informational website.
  • 培训和教育部门研究人员和主要研究人员.
  • 建立临床试验管理的标准操作程序.
  • Provide final signature of agreements and proposals.

随着临床试验办公室的发展,功能和操作的范围 它所能提供的服务可能会随着院系和大学的投入而发展 administrative units.

无论结构如何变化,办事处都致力于密切合作 与大学研究人员和其他研究人员一起优化临床研究 operations across the School of Medicine.